跳至主要内容
临床试验/NCT05914636
NCT05914636尚未招募不适用

Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm: a Comparison of Ruptured and Unruptured Patient With Taxonomic and Metabolic Evaluation of Microbiota

Hospices Civils de Lyon0 个研究点目标入组 50 人开始时间: 2024年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Taxonomic faecal microbiota description

研究概览

简要总结

The physiopathology of intracranial aneurysm from initiation to ruptured is incompletely understood but included inflammation. The microbiota is known to interact with brain and can promote inflammation. The objective of this study is to describe microbiota with taxonomic and metabolomic analysis. A comparison between ruptured and unruptured intracranial aneurysm will be performed. The study hypothesis is that microbiota is different between ruptured and unruptured patient.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • one or more intracranial sacciform aneurysm ruptured or not in function of the inclusion group

排除标准

  • Transient modification of microbiota: Antibiotherapy in the last 3 months, pre or probiotic in the last month, gastrostomy, ileostomy, bariatric surgery, digestive tract resection, gastro-duodenal ulcer surgery or during the last month, chronic inflammatory disease of the digestive tract (like Crohn), BMI for more than 30, Very restrictive diet (like vegan
  • Specific pathologies increasing the incidence of aneurysm ( kidney autosomic dominant polycystosis, Type 1 neurofibromatosis, Rendu-Osler, MArfan
  • Participation to a study with the objective of microbiota modification

结局指标

主要结局

Taxonomic faecal microbiota description

时间窗: The faecal samples will be taken at 3 days+/-2 after the ruptured and during the arteriography for the unruptured group within 3 months after inclusion

The results of the taxonomic analysis of fecal samples will be described in the two groups. Interesting parameter will be selected for further analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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